Pravastatin in HIV-infected Patients Treated With Highly Active Antiretroviral Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- HIV RNA
研究概览
简要总结
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.
详细描述
Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels.
Design. randomized double-blind, multicentric.
Intervention. Pravastatin versus placebo for 12 weeks.
Eligibility criteria. Positive for anti-VIH antibodies, stable antiretroviral therapy including at least one PI for >= 3 months, plasma HIV-RNA level of < 50 copies/mL for >= 3 months before randomization, total cholesterol >= 5.5 mmol/L with LDL-cholesterol >= 3.4 mmol/L on fasting status after three months of standardized dietary advice, written informed consent
Outcomes. HIV RNA at 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ;
- •Age above 18 years
- •Stable antiretroviral therapy including at least one PI for >= 3 months,
- •Plasma HIV-RNA level of < 50 copies/mL for >= 3 months before randomization,
- •Total cholesterol > = 5.5 mmol/L with LDL-cholesterol > = 3.4 mmol/L on fasting status after three months of standardized dietary advice,
- •signed informed consent
排除标准
- •Current AIDS event or infectious disease
- •Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
- •Psychiatric conditions
- •Biological elevated muscular enzymes
- •Chronic alcohol consumption
- •Pregnancy
结局指标
主要结局
HIV RNA
时间窗: at 12 weeks
次要结局
- Lipid biological markers
- Plasma level of protease inhibitors
- CD4 count at 12 weeks
- Safety